Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 16, 2013
August 1, 2013
1 year
August 12, 2013
August 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biological pregnancy test
14 days
Secondary Outcomes (1)
Fetal heart/Gestational sac
8 weeks
Study Arms (4)
Low Molecular Weight Heparin
ACTIVE COMPARATORLow molecular weight heparin, 2500 milli-International unit/day, subcutaneously
Low dose aspirin
ACTIVE COMPARATORLow dose aspirin, 75mg/day, orally
Heparin & Aspirin
ACTIVE COMPARATORHeparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
Sodium chloride (NaCl)
PLACEBO COMPARATOREquivalent volume of NaCl 0.9%, subcutaneously
Interventions
2500 mIU/day, subcutaneously
Aspirin (70 mg/day, orally) \& heparin (40 mg/day, subcutaneously)
Eligibility Criteria
You may qualify if:
- Aged between 19 to 35 years;
- Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
- Presence of both ovaries; ≥2 previous IVF failures
- Good quality embryos for transfer
- Endometrial thickness between 10 mm and 14 mm
You may not qualify if:
- Polycystic ovary syndrome
- Endometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre
Allahābād, Uttar Pradesh, 211003, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vandana Bansal, MS DGO PhD
Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director & Consultant
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 16, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
August 16, 2013
Record last verified: 2013-08